Big step forward for cancer vaccine
MIL/Agencies, Mar 31, 2007.
March 31, 2007 - Medicine's arsenal against cancer could soon include a new class of treatments -- therapeutic vaccines -- now that the first of these products has cleared a major regulatory hurdle.
A Food and Drug Administration advisory panel on Thursday supported approval of Dendreon Corp.'s Provenge, the first cancer vaccine to get so far in the regulatory process. If the agency follows the panel's advice and approves Provenge for metastatic prostate cancer, Dendreon will become a trailblazer with the first product brought to market in the United States in this new drug category.
That could ease the path for other cancer vaccines, opening a whole line of commercial products for biotechnology companies.
"I think it's a positive event for the field as a whole,'' said Dendreon chief executive Mitchell Gold.
Early market reaction suggests that the panel's positive vote on Provenge could be a shot in the arm for the entire class of cancer vaccine developers, boosting the credibility of a field that has seen many failures. Trading in Seattle's Dendreon was halted Thursday pending the advisory panel's recommendation. But shares in Cell Genesys of South San Francisco, whose vaccine GVAX is also being tested in prostate cancer, leapt 8.7 percent after the vote was reported.
Biotechnology companies have struggled for years to develop a therapeutic cancer vaccine or cancer immunotherapy, the term many drug developers prefer. Such a treatment would act like a vaccine by sensitizing the immune system to recognize cancer cells as dangerous invaders and destroy them. Dendreon is the first in the class to reach the runway for FDA approval.
Although cancer vaccine development is considered an extremely risky investment, some big pharmaceutical companies are entering the arena. As the Provenge panel met, French drugmaker Sanofi-Aventis said it has signed a deal worth up to $690 million with the British company Oxford BioMedica to co-develop a therapeutic cancer vaccine. Oxford BioMedica has begun a late-stage trial of its experimental drug TroVax in kidney cancer.
Full Story: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/03/30/BUGDTOTGSK18.DTL
|